1. Field of the Invention
The present invention relates to a protective sheath for winged, butterfly-type needles such as fistula needles or those used in IV infusion sets and to a sheath and needle assembly which includes a protective sheath to protect accidental needlesticks from such needles.
2. State of the Art
Accidental needlesticks from contaminated medical equipment such as syringes and IV equipment poses serious risks to healthcare professionals. Even maintenance personnel who dispose of the used medical equipment are at risk. Hepatitis, AIDS and other diseases can be, and sometimes are, transmitted by accidental needlesticks from needles used on infected patients.
Attempts have been made to combat the problem of accidental needlesticks from syringes. See, for example, the devices disclosed in prior U.S. Pat. Nos. 4,654,034; 4,681,567; 4,740,204, and 4,740,204. Moreover, attempts have been made to specifically prevent needlesticks from IV equipment. See, for example, the devices disclosed in U.S. Pat. Nos. 3,572,334; 4,140,108; 4,160,450; 4,170,993; 4,676,783; 4,781,692; 4,820,282; 4,834,708; 4,846,808; 4,888,001; 4,917,669; 4,935,011; 4,941,881; 4,943,283; 4,969,876; and 5,120,320.
In particular, U.S. Pat. No. 4,941,881 discloses an IV infusion set with a sheath which includes a length of tube having a hollow needle at one end of the tube. A sheath is slidably disposed on the tube and is adapted to be slid over the needle to cover the needle after it has been used. The sheath includes means for locking the sheath in its position covering the needle to prevent needlesticks from the used needle. The IV infusion set is of the type having outwardly projecting flexible wings adjacent the needle and the means for locking the sheath preferably comprise means for engaging the wings. The sheath comprises a hollow generally tubular body having a forward end oriented toward the needle and a rearward end oriented away from the needle. The body has at least one longitudinally extending slot extending from the forward end of the body toward the rearward end. The slot is adapted to receive the wings to allow at least part of the sheath to be slid past the wings to cover the needle. The forward end of the slot widens to a generally V-shaped mouth to facilitate the passage of the wings into the slot. The sheath may include a cut-out in the body at the rearward end of the slot for receiving and engaging the wings to lock the body in its position covering the needle.
My prior U.S. Pat. No. 5,330,438 discloses an improvement to the IV infusion set and sheath disclosed in U.S. Pat. No. 4,941,881, the subject matter of which is incorporated herein by reference thereto. My prior invention affords an improved sheath construction which significantly minimizes the possibility of improper operation and jamming of the used needle relative to the sheath during the sheathing operation.
Recently, the U.S. Food and Drug Administration has requested that all safety devices used with needles either change color or produce an audible sound or provide some other easy-to-recognize evidence that the needle has been rendered safe.
Accordingly, it is an object of the present invention to provide a novel and improved protective sheath for winged, butterfly-type needles such as a fistula needle or the winged needle of an IV infusion set and a sheath assembly which includes such an improved sheath which covers the needle after it is used in order to reduce the risk of needlesticks with the used needle.
It is a further object of the present invention to provide such a protective sheath and sheath assembly, especially for IV infusion sets or fistula needles in which the sheath can be locked into position covering the needle by simply pulling on the tube whereby the needle is retracted into the protective sheath.
It is a more particular object of the present invention to provide such a protective sheath and assembly which is highly effective in operation, easy and facile to use, economical to fabricate and of relatively simple design.
It is still another object of the invention to provide means for producing audible evidence that the needle is safely locked within the sheath.
It is yet another object of the invention to provide means for improving the locking structure of my prior patent.
It is still another object of the invention to provide means for facilitating the movement of the needle into a locked position within the sheath.
It is another object of the invention to provide means for the user to easily recognize where to hold the sheath for proper and safe use.
The foregoing and related objects are readily achieved in an improved winged needle assembly set of the type including a length of tube with a hollow needle at one end, and a pair of outwardly projecting flexible wings adjacent the end of the tubing with the needle and a protective sheath slidably disposed on the tube and adapted to be slid over the needle to cover the needle after use. The sheath comprises a hollow generally tubular body having a forward end oriented toward the needle and a rearward end oriented away from the needle. The body has at least two longitudinally extending fingers separated by slots extending from the forward end of the body toward the rearward end, each of the slots being dimensioned to receive only one of the wings to allow at least part of said sheath to be slid past the wings to substantially cover the needle after use. Preferably, the slots each have a width which is slightly less than the width of one of the wings.
According to the invention, the slots are provided with a z-bend which causes an audible click as the wings pass through it. Moreover, the z-bend has a shallow entry and a steep exit which permits the wings to pass through in one direction for locking and inhibits the wings from exiting in the opposite direction.
According to another aspect of the invention, the sheath is provided with a hilt which facilitates the sliding of the sheath and/or wings into a locked position and prevents the user from holding the sheath by the slotted areas which might prevent the wings from sliding into the locking slots. It also keeps the user""s hands away from the contaminated needle during sheathing.
The protective sheath is preferably made from plastic, and the forward ends of the fingers are preferably V-shaped and tapered to facilitate the passage of the wings into the slots.
Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.